Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients

August 2, 2023 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
We perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Dr. Tollár József

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

post stroke 6MWT : 120> minimum after stroke 3 days be a stroke patient first stroke hemiplegia

Exclusion Criteria:

multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic
They performed training with a robot 15 times over 3 weeks.
Other: Robot
You have to walk with a robot mounted on your lower limb. To move, to change direction.
Other Names:
  • ROB
Experimental: Fizio
They receive physiotherapy treatment.
Other: Fizio
Patients do state-funded physical therapy.
Experimental: EXE1
Virtual reality treatment is performed once a day.
Other: EXE1
Patients undergo intensive virtual reality therapy once a day.
Experimental: EXE2
Virtual reality treatment is performed twice a day.
Other: EXE2
Patients undergo intensive virtual reality therapy twice a day.
Experimental: EXE+ROB
Virtual and robotic treatments are performed once a day.
Other: EXE+ROB
The patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mRS score
Time Frame: 3 weeks (0-5 score, high score better)
3 weeks (0-5 score, high score better)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index score
Time Frame: 3 weeks
3 weeks
Berg balance score
Time Frame: 3 weeks (0-30, high score better)
3 weeks (0-30, high score better)
6MWT
Time Frame: 3 weeks
meter
3 weeks
10m gait speed
Time Frame: 3 weeks
m/s
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKEB/2023/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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